Abbott on Friday presented one-year clinical trial results for the Volt pulsed field ablation system alongside six-month CE mark study data for the TactiFlex Duo catheter to treat complex atrial fibrillation at the AF Symposium in Boston.
The VOLT-AF investigational device exemption study demonstrated an “industry-leading” 84.2% rate of freedom from recurrence in paroxysmal AFib, where episodes come and go, according to Abbott. In addition, about 68% of patients with persistent AFib lasting longer than seven days had no episodes post-ablation.
The one-year outcomes were published in the journal JACC: Clinical Electrophysiology,
Volt is competing with PFA systems introduced in the past two years from Boston Scientific, Medtronic and Johnson & Johnson, as ablation treatment for the abnormal heart rhythm continues to shift to the new technology. The Abbott device obtained Food and Drug Administration approval in December and Europe’s CE mark in March 2025.
Last week, Abbott said that U.S. commercial cases with Volt had begun, and an expansion in Europe continues.
TactiFlex targets complex cases
Abbott gained the CE mark in January for the TactiFlex Duo catheter that can deliver both PFA and radiofrequency energy to allow physicians to tailor treatment in complex cases.
Six-month CE mark trial results for the device, presented at the symposium, showed an 81% rate of freedom from recurrence among paroxysmal patients.
Abbott completed enrollment last year in an IDE trial to evaluate TactiFlex Duo to treat AFib and received the FDA’s breakthrough device designation in October for the device to use PFA in treating ventricular tachycardia, a potentially life-threatening fast heart rate.
„These studies help solidify our treatment offerings for AFib as we strive to challenge the status quo to develop even better tools that physicians can rely on to care for their patients,“ Christopher Piorkowski, chief medical officer of Abbott’s electrophysiology business, said in a statement.
Pulse data exceeds expectations
Pulse Biosciences said last week that the first-in-human trial of its nPulse cardiac catheter showed 96% procedural success at one year in treating atrial fibrillation. The results demonstrated successful treatment in 150 patients with rapid procedure times and minimal adverse effects, according to Pulse. On the study’s safety endpoint, two patients experienced serious adverse events.
Mizuho analyst Anthony Petrone said in a note to investors that the data “easily exceeded” the prior three-month results as well as competitive clinical PFA durability data for the one-year time horizon.
Pulse’s technology delivers nanosecond electrical pulses that are briefer in duration than the microsecond pulses used in other PFA systems. The ongoing feasibility study is assessing the initial safety and efficacy of the system.
David Kenigsberg, chief medical officer of electrophysiology at Pulse, said the findings exceeded expectations, in a clinical field where a 20% to 25% recurrence rate is expected. The company plans to begin treating additional patients in Europe and the U.S. as it initiates its pivotal IDE study, he said.
